Patent Application
20130096693
The invention relates to means of reducing wear in total joint replacements. Wear of Ultra High Molecular Weight Polyethylene (UHMWPE), still the most commonly used articulation material, is considered a major factor contributing to aseptic loosening and thus limiting the duration of artificial joints. Reduction of UHMWPE wear has been an important topic of research and development from the sixties with the increased urgency accorded to the problem in the last decade. Metal-metal combination produces less, but nevertheless, biologically, significant wear. Potential toxicity of metal ions is both, a major concern and a motivation to seek improvements. Here too, relatively even greater reduction of wear is possible by means of this invention. In the case of ceramic-ceramic articulations, the wear is very low, but the precision needed to produce them is extremely high and even minor deviations can lead to failures. This invention can mitigate the problem by reducing the wear principally and thus increasing the overall robustness of the joint and possibly relaxing the need for the exacting production technologies.
Four decades after its introduction into total joint replacement by Charnley, UHMWPE remains the most commonly used material for the concave part of the artificial joints, e.g. for the acetabular cup of the total hip prosthesis, or the tibial plateau of the total knee prosthesis. While it has played a central role in the success and widespread use of joint replacements, UHMWPE has also been identified as a major culprit in the most common mode of their failure—aseptic loosening. Wear particles produced by articulation of the hard, convex, usually metallic, or ceramic component against the soft polymer liner accumulate in and around the joint until the concentration of particles becomes so high that, in spite of the polymer's generally excellent biocompatibility when in bulk, they initiate a biological response leading ultimately to bone loss, loosening of the joint components and dysfunction of the joint replacement.
Different methods of wear reduction have been sought, found and introduced into clinical use over the last few decades, all focused on improving the wear characteristics of the articulation pair at their interface.
On the convex, metallic, or ceramic component these efforts included reducing roughness of the surface, increasing precision of the geometry, e.g. sphericity of the femoral head, and increasing hardness of the materials. Improved wetting of the hard surface has also been identified as an important factor in general wear reduction.
These measures have been realized through:
(i) better selection of and processing of metals, both in metallurgical aspects and in machining methods employed;
(ii) use of hard coatings, added or created in situ, by e.g. oxidation;
(iii) use of bulk ceramic components.
The reduction of wear, both in laboratory testing and from in vivo observations is on the order of factor two.
More recently, modifications of UHMWPE material through cross-linking have gained much attention. Cross-linking can be achieved by physical (irradiation) and/or chemical means. Laboratory testing has shown great variability, mostly due to different methods of wear production and assessment employed. Tests conducted on joint simulators and with careful compensation for artifacts, suggest factor five to ten reduction of wear vs. regular UHMWPE.
A number of potential problems of cross-linking have been mentioned in, by now, vast literature on the subject. Among those is the reduction of strength, particularly in fatigue; reduction of average particle size, making the wear debris biologically more active; and risk of long term degradation in the body.
Cross-linked UHMWPE is in broad clinical use for about five years—too short a time for the final judgment on its benefit-to-risk ratio. Several clinical observations suggest the actual wear reduction of about factor two, but again, there is much variability in methods used to assess the wear and thus in the reported results.
Metal-metal articulations have been used before UHMWPE was introduced in the sixties, which has ever since dominated the clinical use. As the biological problems of UHMWPE wear surfaced in the eighties, metal-metal was re-introduced, with now better metallurgical and manufacturing technologies available and consequently promising the better clinical outcomes. The wear rates, compared to UHMWPE, are on the order of factor ten lower by weight; hundred times by volume. However, systemic accumulation of ions of potentially harmful metals has been observed, and the risks remain unknown, especially in younger patients, who are most in need of improved joint replacements.
Ceramic-ceramic articulations are technically the best in terms of wear, but various regulatory obstacles and the high price have, until recently, kept their use to a small percentage of the total. There are also risks, if relatively low, of component breakage due to extreme brittleness of ceramics and rapid degradation of the articulation due to even minuscule imperfections of, or any damage to the surfaces. Sophisticated technologies and quality controls required in production have also been an impediment to their wider use. This invention offers a potential of wear reduction principally and consequently increased robustness of ceramic-ceramic articulations.
Briefly, the invention improves the wear characteristics of the artificial joint through: (i) reduction/elimination of the contact (Hertzian) stresses; and (ii) improved lubrication at the area of contact.
Both of the effects result from the change in the geometry of the articulating surfaces. In the case of the total hip joint, the standard, state of the art, is the ball-and-socket geometry, e.g. a sphere in a sphere, placing the contact at a point, which due to elasticity of the components results in a more or less spread out, more or less circular area of the contact, with the peak stress in the middle. There are now broadly accepted manufacturing standards specifying sphericity, dimensions and surface finish of the articulations for total hip prostheses.
Novel, optimal shapes of the articulating surfaces for total hip prosthesis according to this invention are either:
(i) a spherical head in an aspherical cup, with a theoretical surface contact over a band centered at about 45 deg. from the axis of revolution, or
(ii) an aspherical head in a spherical cup, placing, again, the theoretical surface contact over a band centered at about 45 deg.
In both cases the aspherical component is a body of revolution, leaving a gap between the articulating surfaces at the area where in the conventionally shaped components the stresses would be the highest. The axes of revolution in both cases should approximate the axes of major in vivo loading in order to maximize the benefit. This makes the production and surgical application somewhat more complicated, but is well justified in view of the need to extract the maximum benefits.
For a spherical articulation, such as used in total hip prostheses, the theoretical point-contact stress changes into a theoretical surface stress, principally eliminating the Hertzian stress, leading to a substantial reduction of the peak stress. Just how much that is, depends on the moduli of elasticity of the two components and the difference in the radii of curvature in the conventional articulation, as well as the width of the band of the surface contact in this novel articulation. In general, the harder the materials used, and the bigger the difference in the radii of the conventional pairs, the bigger the potential improvement. However, in all cases, even with the soft polymeric cup, a highly significant and relevant improvement is possible.
Improved lubrication is perhaps just as important for wear reduction. It is effected by the fluid entrapped between the articulating surfaces in the gap created by the above mentioned geometrical combinations. This fluid is pressurized by the elastic deformation of the components and exuded through the inter-articular gap at the surface contact. In conventionally shaped components the fluid is rapidly lost from the pole (point of contact) leaving the contact area dry. This especially so in the conditions of semi-static load, e.g. at the heal-strike of the gait, where the loads are high and the speed is low. The resulting mode of lubrication is commonly termed “mixed mode”, changing between elastohydrodynamic and boundary mode.
In a gross approximation, the lubrication mechanism of the joint according to this invention resembles “weeping” lubrication of the natural, cartilage covered joint. Under increasing load, as the pool of fluid in the gap is pressurized, fluid is pushed out through the sealing gap between the components; when the load is reduced, and thus the sealing efficiency at the area of contact, the elastic recoil of the components will create an underpressure in the gap and suck the fluid back in. This aspect of wear reduction by the disclosed changes in geometry plays a bigger role in the softer materials, because elastic deformation leading to fluid pressurization is essential for the mechanism to function as described.
Yet another benefit of the invention is the increased stability of the kinematic pair. A ball in an oversized spherical cup can freely rotate about all three axes, but it can also experience a wobble about the pole (point of contact), perhaps a micro wobble, but nevertheless a wobble. This can result in cavitation with all of the surface damage sequelae and ultimately an increased wear rate. Moving the contact away from the pole out to a surface of contact centered at about 45 degrees from the polar axis provides a stable seat for the ball (head of the joint) even as the load moves within its physiological window.
The invention has been reduced to practice as a metal-backed UHMWPE cup liner, shaped as an aspherical body of revolution, and tested for wear up to 5 million cycles against a spherical metal head. The wear was reduced by approximately factor seven to fifteen, in comparison to published results obtained for conventional UHMWPE-metal combinations in the identical or similar test protocols. This matches the results obtained by cross-linking UHMWPE.
Finite Element Method stress analysis has been performed on different combinations of the metal-backed UHMWPE liner of standard spherical shape and of the novel shape, demonstrating over 50% reduction in the peak Von Mises stress in the UHMWPE cup liner.
Predicted theoretical reductions of contact stresses in metal-metal, or ceramic-ceramic joints are even higher, but the role which lubrication may play is difficult to calculate and there is as yet no experimental verification.
Straightforward generalizations to other, more complex, less conforming shapes, e.g. a knee joint, are expected to result in lesser, but still significant reductions of wear.
CH449173, “Gelenkprothese”, by Maurice Mueller, discloses a metal on metal prosthesis, whereby the contact is limited to polymeric pads seated into their recesses within the cup.
DE4423020, “Gelenkprothese”, by Wolfgang Fitz, discloses a hip prosthesis cup with a reservoir for the lubricating fluid in the unloaded, inferior region, combined with grooves, known in general art of sliding bearings as advantageous, because wear particles are more readily removed from the articulation.
DE19604458, “Gelenkpfanne”, by Hagen Seifert, discloses a cup of the hip prosthesis shaped so as to make exclusively a ring contact to the head near the equator, leaving a spherically shaped recess in the cup filled with fluid and thus, enabled by grooves in the contact area, acting as a shock absorber. Controlling the stiffness of the cup, there are a number of ring shaped cavities within the cup wall. The concept is essentially one of a hydrodynamic bearing. Devoid of fluid support (as would happen in any case if the loading persisted long enough, e.g. fractions of a second) it would either result in very high friction torque, if the load were to be supported by the near-equator contact zone, or it would be reduced to a standard bearing (plus the friction at the contact zone) if the head fell into the recess.
DE19915814, “Gelenk-Endoprothese mit verschleissarmer Gleitpaarung”, by Manek Buttermilch, et al., discloses a ceramic-ceramic total hip prosthesis, whereby the contact between the two articulating components is a line contact, made to be that by either a modified head geometry or modified cup geometry. In both cases the mismatch is produced by replacing a single radius of curvature by two, with offset centers, resulting in a line contact. Herzian stresses are reduced, but not eliminated. Geometry of this invention is also characterized by the fact that the aspherical component of the articulation presents a kink (the two circles defining the cross-section of the aspherical component are not tangent) in its contour at the line of contact.
EP0053794, “Cup for a hip joint”, by Manfred Semlitsch, et al., discloses an endoprosthesis, in which both the joint ball and the hip joint cup consist of oxide ceramic material, an annular recess is arranged in the area of the opening of the hip joint cup, in which recess a ring of bioinert, plastically deformable material is situated. The surface of the ring facing towards the joint ball merges essentially without interruption and entirely steplessly into the spherical surface of the cup. In the event of subluxation and an associated short-term, linear-type bearing contact between joint ball and joint cup in the edge area of the cup, the result, even in the case of dry friction, is a favourable tribology between the joint ball and the ring of plastically deformable material which comes into engagement with the ball upon subluxation.
EP0821922, “Hip prosthesis joint component with particulate trap”, by Claude Hubin and Marie Jean Sterpin, discloses a hip prosthesis cup for metal-metal articulation provided with a polar recess which serves as a trap for wear particles. Alternatively, the head can also have a trap/recess.
FR2727856, “Ensemble prothetique auto-lubrifiant pour l'articulation de la hanche”, by Barba Laurent et al., discloses a hard-hard (metal-metal, or ceramic-ceramic) articulation for a total hip prosthesis of such shape and dimensions that a laminar film of synovial fluid can be maintained in use. A reservoir for the fluid is provided at the polar region. No details are provided as to what the geometry of the cup should be to meet the requirement of fluid film lubrication, other than the gap between the cup and the head being in the range of 0.005 and 0.05 mm, which covers the standard radial clearance used in hard-hard bearings.
GB1322680, “Improvement in and related to prosthesis”, by Georges Girard and Ramiro Cameo, discloses a total hip prosthesis, whereby the surface of the head is provided by a pattern of grooves intended to reduce the wear at the articulation. As a prior art, the inventors cite a prosthesis whereby the spherical head is articulating against a cup of “football shape”, i.e. elongated, which leads to a line contact, rather than a point contact.
US2002/0116068, “Containment system for constraining a prosthetic component”, by Terry McLean, describes a truncated head of the total hip prosthesis which can be inserted into the cup sideways through the slots in the opening of the cup before turning into the functional position. This results in the head being retained within the cup which covers more than 180 degrees. The unintended result is that the conventional point contact is now changed into a line contact along the edge of the truncated segment of the head.
US2005/0246026, “Modular orthopaedic implant apparatus”, by Paul Lewis, et al., discloses a modular acetabular cup comprising three elements, which can be combined in different ways to allow the surgeon the choice of implants of varying sizes and features. Fixation is through a central bore of all three, thus, like in U.S. Pat. No. 6,527,809, changing the point contact into line contact along the edge of the liner.
US2005/0261776, “Prosthetic joint with annular contact bearing surface”, by Scott Taylor, discloses a truncated, or annular, acetabular component of a total hip prosthesis, whereby the contact of the head and the inner of the two members of the cup occurs along a line instead of at a point.
U.S. Pat. No. 5,181,926, “Bone implant having relatively slidable members”, by Rudolf Koch and Robert Streicher, describes a total hip prosthesis, whereby the cup side, within cavities in its polymeric liner, contains self-aligning pads of hard material which articulate against the head.
U.S. Pat. No. 5,549,693, “Cotyloidal prosthesis”, by Christiane Roux and Michel Pequignot, discloses a total joint prosthesis, whereby the cup side contains at its opening a ceramic ring, much like a natural labrum, which forms a seal to the ceramic head. Position of the ring is such that the frictional moment of the couple would be very high.
U.S. Pat. No. 5,593,445, “Bi-axial prosthetic joint”, by Thomas Waits, describes a total joint prosthesis whereby a third, ring-shaped, member is interposed between the head and the cup, increasing the contact area under load, self-aligning between the head and the cup in the direction of the load.
U.S. Pat. No. 5,702,456, “Implant having reduced generation of wear particulates”, by David Pienkowski, discloses a method of pre-wearing the prosthesis before implantation, whereby the usually somewhat increased amounts of particles produced by wear-in process do not burden the body. Only a minimal improvement for the long term outcomes could be expected from such a procedure.
U.S. Pat. No. 5,725,593, “Total anatomic hip prosthesis”, by Francesco Caracciolo, discloses a resurfacing total hip prosthesis, whereby the femoral cup has multiple circular rises, intended to reduce the friction within the spherical cup.
U.S. Pat. No. 5,766,258, “Wrist prosthesis”, by Beat Simmen, discloses a wrist prosthesis, whereby in one of the embodiments of the invention one of the two separate articulations is produced with non-circular members so that they tend to fall, or self-center, into a stable position, in which they become congruent.
U.S. Pat. No. 6,527,809, “Trial acetabulum or implantable acetabulum with adjustable orientation”, by Levon Doursounian and Michel Porte, discloses a modular acetabular cup, whereby the cup inlay which articulates against the head has a central opening allowing access to the mechanism of locking the cup in the desired position. This, as a side effect, defines the contact conditions between the head and the inlay as a line contact along the edge of the central opening, as is the case in U.S. Pat. No. 4,840,631, “Artificial hip joint socket with hydraulic head support”, by Robert Mathys, but without the hydraulic pressure support disclosed by Mathys.
U.S. Pat. No. 4,031,570, “Prosthetic acetabulum”, by Otto Frey, discloses a torus-shaped aspherical cup with the radius of the curvature equal to that of the spherical head, but with the center of the curvature offset from the central axis so as to avoid jamming of the head in the cup, changing the theoretical point contact of a sphere in a spherical socket into a line contact of a sphere in a toroidal socket, and further, for the purpose of improved lubrication, a groove at the periphery of the cup and a recess/pocket at the pole. Hertzian stresses are reduced by changing from the point to line contact, but not eliminated as by the current invention which changes point to surface contact.
U.S. Pat. No. 4,840,631, “Artificial hip joint socket with hydraulic head support”, by Robert Mathys, discloses a hip joint articulation with a cylindrical recess machined into the cup so as to create a reservoir for the joint fluid, which would pressurize under the load, sealing provided by the edge of the recess. The disadvantage of this solution is in the high stresses produced at the edge of the recess, which could lead to localized wear, potentially to loss of the seal and hence of hydraulic support.
U.S. Pat. No. 5,336,267, U.S. Pat. No. 5,383,936, U.S. Pat. No. 5,738,686 and U.S. Pat. No. 6,312,471 by Dietmar Kubein-Meesenburg et al. disclose theoretical basis and solutions to reducing stresses in articulations of joint prosthesis, all of which lead to theoretical line contact instead of point contact. Hertzian stresses are reduced, but not eliminated.
GB 1322680, “Prosthesis”, by Georges Girard et al. discloses a metal-metal total hip joint articulation, whereby the concave, cup, component is provided with multiple groves leaving only protrusions ending on a spherical surface to contact the spherical head. This type of contact is proposed to reduce the risk of jamming of conventional, smooth, spherical surfaces of a ball-in-socket joint, specifically in metal-metal combination, where the required tolerances are tight and difficult to maintain in production.
U.S. Pat. No. 6,645,251, “Surfaces and processes for wear reducing in orthopaedic implants”, by Abraham Salehi et al. discloses an approach based on grooving the concave surface in order to improve lubrication and distribute the stress. As known from technical sliding bearings, the main advantage of grooves comes from improved removal of wear particles away from the articulation. Fluid entrapment may play a role in improved lubrication as well. However, grooves as disclosed may in fact lead to higher local stresses at the edges of the grooves and defeat the purpose. There has been no published data supporting the concept and no evidence of even limited acceptance of this approach by the orthopaedic device industry.
U.S. Pat. No. 6,425,921, “Sliding partners for artificial joint implants”, by Hans Grundei and Wolfram Thomas, discloses an alternative approach where the grooves are produced in the convex component of the joint. Actual hip simulator tests performed on this type of joint components did not show any wear reduction.
None of the cited documents, nor any combination of them, teaches those skilled in art how to design an articulation for an artificial joint which principally eliminates Hertzian stresses at the contact and still allows for movements with low frictional torque.
Practical limitations on accuracy of the machinable components, including effects of temperature and of radiation-induced shrinkage, if used for sterilizing polymeric cups, and the safety against jamming of the components when used in the body, have led to international standards which guarantee acceptable in vivo performance.
ISO standards 7206-2; 27.80 to 28.00 and 7206-2; 28.10 to 28.30 specify the geometry and dimensions of the head and cup components, respectively, of a total hip prosthesis.
Sphericity and dimensional tolerance of the head component—The metal or ceramic femoral head component of a total hip prosthesis shall have a departure from roundness of not greater than 10 micrometers. If used against hard material cups (metallic or ceramic) it will not be greater than 5 micrometers. The diameter shall be equal to nominal diameter+0.0, −0.2 mm. For metal-metal or ceramic-ceramic articulations the tolerances are not specified, but in all cases there shall be radial clearance. In practice, the heads are today produced with significantly tighter specifications than required by the standards.
Sphericity and dimensional tolerance of the cup component—For polymeric component the sphericity is not specified; for hard materials it shall not exceed 5 micrometers. The dimensional tolerance for polymeric cup is +0.3, +0.1 mm at 20.+−0.2 deg. C. from the nominal diameter. In practice, UHMWPE cups are oversized by at least +0.2 mm over the nominal diameter. No tolerance for the metallic or ceramic cups are given, but the radial clearance must be guaranteed by the producer. Typical radial clearance for hard pairs is in the range of 0.02 to 0.030 mm.
a is a perspective view showing a theoretical band of contact on a spherical surface.
b is a schematic view of theoretical surface contact over an arc of a spherical surface.
a)-(c) are perspective views of a total hip articulation showing contact area under load.
For a simple and clear presentation, a total hip joint articulation has been chosen for this disclosure, but the same technical arguments and design approaches can be used for articulations of other joint prostheses, which, generally, have less conforming surfaces and lesser degree of coverage.
Diameter 15 of the cup opening is larger than the diameter 14 of the head 2, so that the head 2 can freely come into its seat within the cup and make the contact at point 9. Under load the point contact will spread out into a surface contact, resulting stresses being known as Hertzian, after Heinrich Hertz, who with his 1882 classic publication has provided theoretical basis for calculating contact stresses between bodies of simple geometrical forms (Hertz, H.:“Gesammelte Werke”, vol. I, Leipzig, 1895). Formulas to calculate Hertzian stresses are given in e.g. “Formulas for Stress and Strain”, Fifth Edition, Roark and Young, McGraw-Hill, 1982, Chapter 13. The subject is extensively covered in e.g. “Contact mechanics”, K. L. Johnson, Cambridge University press, 1985. For a sphere in a spherical socket the formulas are valid only if the radius of the socket is larger that that of the sphere; improved formulas for closely matching radii have also been developed, but if the radii are equal, the contact stress in the Herzian sense is eliminated.
For polar angles larger than 114 the radius of curvature 104, of the surface 103, with the center at 105, is larger than the radius 107, opening a gap between the two articulating surfaces 103 and 106.
For polar angles just smaller than 113, the radius of curvature of the surface 103 is also larger than of the surface 106, again opening a gap 111. As the polar angle approaches zero, the radius of curvature of the surface 106, is decreased to round off the shape of the cup at the pole 109. The resulting gap at the pole is 118.
The arc of circle 120 of perfect congruency is centered at the polar angle 115, and its corresponding width angle is 116.
The position, 115, and the width, 116, of the band of theoretical surface contact are subject to parametric optimization. First order approximation suggests that the angle 115 should be about 45 degrees; the width 116 about 30 degrees. Theoretical optimizations, coupled with experimental testing, including a cost-function placed on the frictional moments of the articulation, are expected to place the angle 115 into the range between 20 and 50 degrees; the surface contact width 116 into the range between 10 and 40 degrees.
The band of contact 121, shown in a perspective view on
Opening 140 of the cup is larger than the diameter of the head 141, resulting in the clearance 117, so that the head is free to seat itself into the cup generating a surface contact along the area 121.
The type of cups shown on
The scale of the fossa gap is greatly exaggerated on this and on the following figures. In reality, it will depend on the materials used. For an UHMWPE cup of the fossa type the maximum gap size, which conveniently would be 118 at the pole 109, should be big enough, so as to avoid bottoming out of the head 102 even after maximum anticipated use of the prosthesis, e.g. for 50 years. The wear tests conducted until now suggest the rate of about 4 micrometers per million cycles of loading, which may correspond to 1 to 2 years of in vivo use. To allow for 50 years of wear without bottoming out, the gap 118 should be 0.2 to 1 mm; 2 mm would give a safe margin, but this may call for fairly significant changes of the radius vector 104 for the polar angles between the axis 110 and the first angle of contact 113.
Ideally, the changes of the radius of curvature of the surface 103 below and above the angles 113 and 114, respectively, should be continuous, but for practical reasons one or two steps will suffice, especially if machined in the soft polymeric materials like UHMWPE. It is highly preferable, though, that the transitions are tangential, i.e. that the contour of 103 is smooth, as shown in
For metal-metal and ceramic-ceramic articulations the gap 118 should be about 5 to 10 times smaller than for UHMWPE; i.e. in the range from 50 to 200 micrometers.
To minimize the production of wear, international standards (ISO, ASTM) have proposed the upper limits on the roughness of the articulating surfaces: (i) UHMWPE cup maximum Ra of 2 micrometers (approximately grade N7); today, UHMWPE cups are typically machined to surface roughness of N5 to N6, corresponding to Ra of 0.4 to 0.8 micrometers; (ii) metal or ceramic heads maximum Ra of 0.05 micrometers (grade N2); ceramic heads are typically finished with Ra of less than 0.01 micrometers.
Notwithstanding the value of the standards, in light of the importance of maximizing the efficiency of dynamic lubrication, the surface finish of the inner surface of the cup, and particularly of the UHMWPE cup, should not be uniform over the entire surface. The unloaded, theoretical surface contact over the arc 120,
This type of heads will be referred to as fovea type. Fovea also means a pit or cuplike depression and is used to describe the recessed or flattened area of the femoral head where the round ligament inserts.
Ideally, the changes of the radius of curvature of the surface 206 below and above the angles 213 and 214, respectively, should be continuous, but for practical reasons one or two steps will suffice. It is highly preferable, necessary in fact, that the transitions are tangential, i.e. that the contour of 206 is smooth.
Which one of the two solutions is more appropriate depends on the materials and manufacturing technologies employed. For example, if UHMWPE is used for the cup with either a metal or a ceramic head, making the cup aspherical is much easier than making the heads aspherical. This especially so if the cup is compression molded.
For metal-metal, and probably for ceramic-ceramic combinations it may well be easier to produce a fovea head than a fossa cup.
To get the maximum benefit of either geometry, the axis 110, respectively 210, should be directed into the window of functional, physiological force vectors acting on the articulation.
In case of UHMWPE cup, this non-linearity can be enhanced by provision of a gentle undulation in the shape of the cup over the contact area, i.e. by providing an interrupted area contact 54,
The joint prosthesis articulation of the present invention may also be incorporated into a total shoulder prosthesis, a total finger prosthesis, a total elbow prosthesis, a total wrist prosthesis, or a total ankle prosthesis.
There are many ways to approach the practical problem of designing more or less optimized shapes of different articulations. Simple analysis, based on known formulas for Hertzian stresses, can be used to guide the design aiming to minimize the contact stresses. For a ball-and-socket joint, assuming no friction at the gliding surfaces, the result is straightforward, suggesting the optimum solution with the contact area centered at 45 degrees. Introducing friction, shifts the optimum angle downwards. And since the invention changes the mode of lubrication, hence the coefficient of friction, the problem of exactly solving for an optimum quickly becomes much more complex. Finite element method can be used to solve for solid stresses, and the optimum design can be sought by either parametric approach, or by min-max methods. Ultimately, fluid flow analysis could be incorporated into these models as well. To minimize the wear in the actual use, however, another, very serious escalation of complexity would have to be brought in—the mechanism of wear and the presumed regimen of use.
An alternative approach would be to start with analysis of the existing articulations, and then, by iteration, remove some material from a chosen side of the articulation, at the areas of maximum stress, aiming to minimize the peaks. For reduction of wear, a cost function should be created penalizing the locations prone to produce more wear in presumed physiological use, i.e. those which experience high relative motion when under load.
The inventor has taken a pragmatic approach of using the ready formulas for Hertzian stress to guide design of the UHMWPE cup for a total hip prosthesis and then performing the actual wear testing in hip simulators against a standard metal head to verify the reduction of wear. There are now internationally accepted standards for wear testing (ISO 14242-1:2002-03), which allow for relatively safe comparisons between different laboratories and different test runs. Whatever the design process, experimental results are ultimately needed to prove the value of inventions in this area. The UHMWPE cup tested was exposed to conventional gamma sterilization, yet the wear rate (3.5 mg/mio cycles) against a 28 mm metal head was at the level of that of highly cross-linked UHMWPE (4 mg/mio cycles). The wear of standard UHMWPE cups has been measured under similar conditions in the range of 35 to 50 mg/mio cycles.
This superior outcome of the testing is due to probably all three important aspects of the invention: reduction of stresses in UHMWPE; improved dynamic lubrication at the contact areas; and improved stability of the joint under varying load vectors. Dispersion of the wear rates was also extremely low compared to conventional designs, suggesting reduced risk in clinical use due to unavoidable specimen variability.
Regarding terminology used in the disclosure, the crucial concept is that of congruency of the articulating pair over a defined area of contact. The theoretical concept of congruency is simple and unambiguous, but in practice it is a subject to practical limitations of achieving it. The production tolerances set a limitation on what can be achieved in terms of matching the shapes of the two components. As the production methods and the tolerances change rather rapidly, setting the limits of what congruency means for the years of the patent life is not possible. Therefore, when the term congruency is used, and unambiguously related to what is meant by equal radii, it defines the intent and the outcome of the intent as materialized in the product, produced by the state of the art technology. The intent to produce congruent components routinely covers the anticipated changes of the dimensions and the shapes due to complete production and ultimate conditions of use, such as influence of sterilization (e.g., gamma sterilization results in the shrinkage of UHMWPE) mounting of the components (e.g. use of press fit into a metal backing) and temperature during use in the body. Those skilled in art at any particular time period and technology level know what meaning to attach to congruent surfaces—this knowledge is implied in the use of the term in this text.
When faced with a possible issue of infringement one could envision a functional test whereby the two components would be brought into articulation and loaded with a tare-load to estimate the extent of contact. Tare-load, however, is not of a fixed value, but rather a function of the particular joint in question and would be determined for the particular articulation by using a conventional design as a control. For example, a conventionally designed metal-UHMWPE pair under a load of 100 N (approx. 5% of average peak load in walking) would show a circular contact area at the pole, whereas the pair designed to the specifications presented in this disclosure would show a ring of contact centered at approx. 45 degrees and about 30 deg. wide.
This application is a continuation under 35 U.S.C. 120 of U.S. patent application Ser. No. 12/515,323 filed May 18, 2009, now U.S. Pat. No. ______, which is a 35 U.S.C. 371 National Phase Entry Application from PCT/EP2007/009944, filed Nov. 16, 2007, and designating the United States, which claims the benefit under 35 U.S.C. 119(e) of U.S. Provisional Application No. 60/859,491, filed Nov. 17, 2006, the respective disclosures of which are hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 60859491 | Nov 2006 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 12515323 | May 2009 | US |
| Child | 13664528 | US |
